Brand Name | LEGACY 2 IMPLANT |
Type of Device | DENTAL IMPLANT |
Manufacturer (Section D) |
IMPLANT DIRECT SYBRON MANUFACTURING LLC |
3050 east hillcrest drive |
thousand oaks CA 91362 |
|
MDR Report Key | 9127958 |
MDR Text Key | 160313650 |
Report Number | 3001617766-2019-03992 |
Device Sequence Number | 1 |
Product Code |
DZE
|
UDI-Device Identifier | 10841307101321 |
UDI-Public | 10841307101321 |
Combination Product (y/n) | N |
PMA/PMN Number | K090234 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Remedial Action |
Inspection |
Type of Report
| Initial,Followup |
Report Date |
10/17/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/27/2023 |
Device Catalogue Number | 824211 |
Device Lot Number | 131416 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/17/2019 |
Initial Date Manufacturer Received |
08/28/2019
|
Initial Date FDA Received | 09/27/2019 |
Supplement Dates Manufacturer Received | 10/03/2019
|
Supplement Dates FDA Received | 10/17/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|